User Manual
Table Of Contents
- 1 Product Description
- 2 General Safety Instructions
- 3 Implantation
- Implantation Procedure
- Having parts ready
- Keeping an external defibrillator ready
- Unpacking the device
- Checking parts
- Implantation site
- Preventing leakage currents
- Preventing unintentional shock delivery
- Avoiding damage to the header
- Preventing short circuits in the header
- Ensure that connections are clean
- Connecting the lead connector to the device
- Keeping distance between leads
- Implanting
- Applying the programming head
- Establishing telemetry contact
- Activating ICD therapy
- Precautionary Measures while Programming
- Performing standard tests and monitoring the patient
- Cancelling telemetry
- Avoiding critical parameter settings
- Checking for electrodes suitable for the shock path
- Monitoring the patient when setting asynchronous modes
- Setting sensing
- Preventing device-induced complications
- Preventing conduction of atrial tachycardia
- Observing the shock impedance limit
- Preventing recurrence after therapy shock
- Phrenic nerve stimulation that cannot be terminated
- Avoiding risks in the case of exclusive LV pacing
- Recognizing lead failure
- Considering power consumption and service time
- Magnet Response
- Follow-up
- Patient Information
- Replacement Indications
- Explantation and Device Replacement
- Implantation Procedure
- 4 Parameters
- Bradycardia / CRT
- General ICD therapy
- Timing: Basic rate day/night and rate hystereses
- Timing: AV delay
- Timing: Post-shock pacing
- Timing: Upper rate
- Timing: Mode switching
- Timing: Ventricular pacing supression
- Timing: Ventricular pacing
- Timing: Refractory periods and blanking periods
- Timing: PMT protection
- Timing: Rate adaptation via accelerometer
- Timing CLS-Modes: Closed Loop Stimulation
- Pacing: Pulse amplitude and pulse width
- Pacing: Ventricular capture control
- Pacing: atrial capture control
- LV lead configuration with IS-1
- LV lead configuration with IS4
- MRI program
- Tachycardia
- Sensing
- Diagnostics
- Home Monitoring
- Bradycardia / CRT
- 5 Technical Data
12
Unpacking the device
•
Peel the sealing paper off of the outer blister at the marked position in the direction
indicated by the arrow. The inner blister must not come into contact with persons
who have not sterilized their hands or gloves, nor with non-sterile instruments!
•
Take hold of the inner blister by the gripping tab and take it out of the outer blister.
•
Peel the sealing paper off of the sterile inner blister at the marked position in the
direction indicated by the arrow.
Checking parts
Damage to any of the parts can result in complications or technical failures.
•
Check for damage before and after unpacking all parts.
•
Replace damaged parts.
•
The ICD is shipped with tachyarrhythmia therapy deactivated and is only to be
connected and implanted in this state.
•
Leads must not be shortened.
Implantation site
•
Depending on lead configuration and the patient's anatomy, the ICD is generally
implanted subpectorally on the left side.
Preventing leakage currents
Leakage currents between the tools and the device must be prevented during implanta-
tion.
•
Electrically insulate the patient.
Preventing unintentional shock delivery
Avoiding damage to the header
There is a blind plug for DF-1 and IS-1 connections in the header. The provided set
screws must be carefully loosened or tightened.
•
Loosen set screws with the supplied screwdriver. Use only BIOTRONIK screw-
drivers with torque control!
•
Do not forcibly pull out the blind plug!
•
If lead revision is necessary, re-order sterile screwdrivers from BIOTRONIK.
Preventing short circuits in the header
Ensure that connections are clean
In case of contamination during implantation:
•
Clean lead connectors with a sterile cloth.
•
Rinse connection only with sterile water.
W
WARNING
Inadequate therapy due to defective device
If an unpacked device is dropped on a hard surface during handling, electronic parts
could be damaged.
•
Use a replacement device.
•
Return the damaged device to BIOTRONIK.
W
WARNING
Shock delivery with activated ICD
There is a risk of unintended shock delivery when handling an activated ICD.
•
Deactivate ICD therapy before touching the device during implantation, device
replacement and explantation.
W
WARNING
Short circuit due to open lead connector ports
Connector ports in the header which are open and thus not electrolyte-proof may
cause undesired current flows to the body and penetration of body fluid into the
device.
•
Either leave unused ports closed with the premounted blind plugs, or close them
using the supplied blind plugs.